Injectafer and Severe Hypophosphatemia

When prescription drugs work the way they are supposed to, they can vastly improve quality of life.

But, sometimes, the medications people take have drastic consequences. Unknown to them, these pharmaceutical drugs are linked to the development of diseases and conditions, some of them serious and even fatal.

If you believe that a prescription drug has hurt you or your loved one, you may be entitled to compensation. Pogust, Braslow & Millrood are Pennsylvania attorneys skilled at representing people who are harmed by pharmaceutical drugs, medical devices, medical malpractice, discrimination, or simply by someone else’s negligence. Contact us at 888-348-6787 to learn how we may be able to help you.

Did You Take a Prescription Drug for Iron Deficiency Anemia (IDA)?

Iron deficiency anemia, caused when the blood lacks adequate red blood cells to transport oxygen to the body’s tissues, leaves those who suffer from the condition feeling tired and out of breath. As the illness progresses, individuals may find that they develop cold hands and feet, experience headaches, and feel weak, dizzy, and lightheaded.

The standard treatment for iron deficiency anemia is taking iron supplements orally, along with vitamin C to enhance absorption. However, it can take months for the body’s iron levels to become optimal. Moreover, many people find that they cannot tolerate oral doses of iron, particularly if they are taking antacids or have impaired gastric acid production.

For people who prefer a quick remedy, or who cannot tolerate oral iron supplementation, doctors may prescribe an intravenous iron replacement.

Injectafer Has Been Linked to Severe Hypophosphatemia (HPP)

The drug Injectafer (ferric carboxymaltose) is an iron replacement product designed to work quickly to restore iron levels. The drug is injected intravenously by a healthcare professional in two doses, seven days apart. How much of the drug you receive depends on how much you weigh; the maximum cumulative dose per treatment (over the course of two injections) should not exceed 1500 mg.

Nausea and irritation at the injection site are common, warned-of, side effects. A more severe and unwarned of side effect is Severe Hypophosphatemia (HPP).

If you experience confusion, weakness, or an irregular heartbeat after being treated with Injectafer for your iron deficiency anemia, it could also be a sign that you have developed severe hypophosphatemia (HPP), which is a severe deficiency of phosphate (phosphorous) in the body. Typically, this condition develops when people either cannot absorb phosphate through their intestines or they are malnourished. However, severe hypophosphatemia has also been linked to drugs like Injectafer.

Clinical studies involving Injectafer overwhelmingly point to Injectafer’s propensity to cause hypophosphatemia and severe hypophosphatemia at rates drastically higher than its competitor iron supplements. Notably, Injectafer does not warn about severe hypophosphatemia, and in fact downplays the type of hypophosphatemia that a patient may experience by using descriptors in its labeling such as “asymptomatic” and “transient.” Just the opposite is true: severe hypophosphatemia is incredibly dangerous and can result in long-term damage, or even death.

One very recent clinical study found severe hypophosphatemia occurring in 38.7% of over 1,000 individuals tested who had taken Injectafer, versus a rate of only .4% for individuals who took a competitor product. Another study estimated that Injectafer presented a 20-fold risk of hypophosphatemia over its competitor iron supplement.

Many experts in the field believe Injectafer’s propensity to cause severe hypophosphatemia at such greater rates has something to do with the gene FGF23, which regulates a protein called fibroblast growth factor 23. Too much fibroblast growth factor 23, and the kidneys stop reabsorbing phosphate. Research shows that, following an intravenous iron injection, FGF23 increases dramatically.

What Is the Prognosis for Severe Hypophosphatemia?

Depending on its severity, chronic HPP may have no symptoms and can go unnoticed. Typically, it results from an underlying hormonal condition such as Cushing’s Disease. Because the levels of phosphate become low slowly, over a period of time, it is a less serious condition.

Severe HPP, on the other hand, is a dangerous condition signaling a rapid, sudden drop in phosphate levels. It can lead to seizures, muscle weakness, respiratory failure, heart failure, coma, and even death if not treated in time. Mild or moderate forms of the condition may be treated with oral phosphate and vitamin D supplementation; severe cases require intravenous injections of phosphate. Severe hypophosphatemia has also been linked to conditions such as rhabdomyolysis and osteomalacia (a long-term bone disease).

We Can Help You Determine Whether You Have a Case

Pogust, Braslow & Millrood are experienced in helping clients to recover damages from pharmaceutical drug manufacturers. We will fight tirelessly to make sure you are treated fairly and receive the compensation you deserve if you have been harmed by using Injectafer to treat your iron deficiency anemia. Call us toll free at 888-348-6787, or direct to our Pennsylvania office at 610-941-4204, to see if you are entitled to seek damages.